IBS-D FDA Drug Approval
#363779 - 03/01/11 04:38 AM
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I received this eMail this morning in an eMail from Jeffrey, the leader of the "IBS Self Help and Support Group":
Dear IBS Self Help and Support Group Member:
I am writing to you today to ask our United States-based IBS Group members to send an immediate email to the Food and Drug Administration (FDA) to let them know, in your own words, what it means to suffer from IBS.
Within the next week the FDA will be making a critical decision as to whether a medication, which is seeking approval to be marketed for IBS, will be approved. This decision has the potential to affect all future drug therapies for IBS and that it is why it is essential that the FDA hear directly from patients. We believe that the FDA may make decisions about medications for IBS based on the incorrect assumption that IBS is a benign illness, which can be controlled by simple lifestyle changes. We are asking our members to inform the FDA what it is really like to suffer from IBS. It is imperative that the emails be sent by March 2, 2011.
Example email: I have no control on the timing of my illness. I have crippling abdominal pain and diarrhea that strikes me at anytime. I cannot carry on every day activities such as working or shopping or attending my daughter's soccer games. It is no simple matter to control the symptoms. I rely on researchers to develop treatments and medications which can allow me to live a more normal life. I am willing to accept virtually any risk associated with new medications.
Send your emails to the following individuals by clicking on each email address. Please include the city and state where you are located (only US-based members may send emails).
Janet Woodcock, M.D., Office of the Center Director CDER janet.woodcock@fda.hhs.gov
John Jenkins, M.D., Office of New Drugs Director CDER john.jenkins@fda.hhs.gov
We trust that the FDA will reflect on these stories when making decisions that affect all of us for this and all future IBS medications.
Thank you so much for your continued support!
Jeffrey
I sent the requested  eMails to the indicated members of the FDA. Do the same if you want to.
Cheers.
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ibs-d (pseudo)with pain and bloating
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Let's hope ...
#363782 - 03/01/11 06:05 AM
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Syl
Reged: 03/13/05
Posts: 5499
Loc: SK, CANADA
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the FDA makes a decision based on the merit of the drug as shown in clinical trial not on the emails sent by non-expert IBS suffers.
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STABLE: ♂, IBS-D 50+ years - Science of IBS
The FODMAP Approach to Managing IBS Symptoms
Evidence-based Dietary Management of Functional GI Symptoms: The FODMAP Approach
FODMAP Chart & Cheatsheet
The Role of Food & Dietary Intervention in IBS
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He makes this important political point about the future attempts from Drug makers for trials of IBS Drugs in this earlier correspondence:
Is there a future for IBS drug therapy?
The US Food and Drug Administration (FDA) has declined a new indication for a drug which is already marketed (see http://www.ibsgroup.org/forums/index.php?%2Ftopic%2F136681-salix-pharmaceuticals-says-it-expects-the-us-fda-to-decline-approval-of-its-drug-xifaxan-in-its-current-form-to-treat-non-constipation-ibs%2F ).
The drug company jumped through hoops to provide sufficient patients during clinical trials despite the FDA changing the endpoints for the drug during the trials. We believe the safety profile of the drug is stellar. Studies indicated that a greater percentage of patients benefited from the drug than placebo and better than some existing therapies.
So, we ask the question: Why would any other Pharma spend millions to bring a drug to the FDA only for it to be denied? This is the 3rd time this has happened at the FDA.
We believe it would be in IBS patients best interest to act now to educate the FDA on the quality of life issues that IBS sufferers must endure. If we don't act now then I believe we will be abandoned by the pharmaceuticals.
If you suffer from IBS, I encourage you to write to these individuals at the FDA to let them know, in your own words, what it means to suffer from IBS. Post your email below and any response you receive.
CENTER FOR DRUG EVALUATION AND RESEARCH
OFFICE OF THE CENTER DIRECTOR
DIRECTOR
Janet Woodcock, M.D.
woodcockj@cder.fda.gov
CENTER FOR DRUG EVALUATION AND RESEARCH
OFFICE OF NEW DRUGS
DIRECTOR
John Jenkins
jenkinsj@cder.fda.gov
Cheers.
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ibs-d (pseudo)with pain and bloating
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The more important point is why did the FDA approve drug like Zelnorm when it was apparent from the clinical trials that there was serious problems with the drug. I happen to have some insight into the problems that showed up during the clinical trials that eventually resulted in the removal of the drug when give to a larger population. By the way - this is happening to more drugs recently approved by the FDA. Recall they got they hands slapped a year or two ago for approving a number of what are now known to be problematic drugs.
There are many drugs that are approved to one treatment but not approved for another treatment. Rifiximan happens to be one of the those drugs. It is indeed effective for the treatment of traveler's D but the current trials show it is only marginally effective for IBS. Let's see what the experts have to say on the matter next month!
While it is nice to let the FDA know that there are plenty of suffers with IBS it makes no sense to get involved in the decision of whether a drug is effective for treating IBS. That is the sort of thing that should be based on clinical evidence only not on patient sentiments about wishes to have a drug therapy alternative.
Where is the evidence that "If we don't act now then I believe we will be abandoned by the pharmaceuticals"? This sounds like pure scare mongering.  Have you looked at drugs that are currently in US clinical trials for treating IBS? There doesn't seem to be any evidence of a decrease.
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STABLE: ♂, IBS-D 50+ years - Science of IBS
The FODMAP Approach to Managing IBS Symptoms
Evidence-based Dietary Management of Functional GI Symptoms: The FODMAP Approach
FODMAP Chart & Cheatsheet
The Role of Food & Dietary Intervention in IBS
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As I am sure you know, when it comes to politics, it is not a matter of evidence or what is right or wrong. "THE SQUEAKY WHEEL GETS THE OIL". We have to let it be known that we want research to go on. Also, as Jeffrey says, Rifaxamin has a very benign record of harmful side effects.
Cheers.
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ibs-d (pseudo)with pain and bloating
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I sure hope politics does not play a big role in determining if a drug gets FDA approval. It would be a shame.
Please direct me to a clinical trial of long term use of the antibiotic Rifaxamin that shows it is benign? It may have minimal side effects in short term use but to the best of my knowledge that are no long term studies on the effect of prolonged use as stated in the editorial about the Rifaxamin study that say "studies that will assess the longer-term effect of rifaximin treatment are eagerly awaited. Until this information becomes available, it seems prudent to restrict the use of nonabsorbable antibiotics to patients in whom small-intestine bacterial overgrowth has been confirmed, or to single-treatment cycles in patients who have IBS without constipation and who have not had a response to currently available symptom-directed therapies"
It may be a good idea to express wishes for more research. It is another thing to promote a email campaign to try influence the decision on the approval of a drug. The later is rather misguided - IMHO.
Cheers
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STABLE: ♂, IBS-D 50+ years - Science of IBS
The FODMAP Approach to Managing IBS Symptoms
Evidence-based Dietary Management of Functional GI Symptoms: The FODMAP Approach
FODMAP Chart & Cheatsheet
The Role of Food & Dietary Intervention in IBS
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I don't know about Canada, but in the US, politicians seem to get involved whenever large sums of dollars are at stake. But in this case by politics I mean the IBS community exercising their influence en mass with the FDA - similar to writing a letter to a congressman about other issues of concern.
By the way, Rifaxamin is not currently approved by the FDA for either SIBO or for IBS-D (single treatment or not). A Dr. can prescribe it, but insurance will not pay. When I had it (for 4 weeks) in 2006 for SIBO it cost about $220 for each 2 week period - total $440. It did not help but did not seem to do any harm either. It did not eradicate my SIBO either.
Cheers.
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ibs-d (pseudo)with pain and bloating
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Canadian approval is very similar to the FDA approval although it takes a bit longer.
It would be nice to see the IBS community puts its influence and support behind a more general and significant causes like Bill H. RES. 1309 which lobbies for more research.
Trying to influence the decision on drug approval is probably not the way to do it and it could have a negative influence. 
Anyway - I eagerly await the decision of the FDA to see how they are going to handle approval of a drug that show marginal clinical benefits
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STABLE: ♂, IBS-D 50+ years - Science of IBS
The FODMAP Approach to Managing IBS Symptoms
Evidence-based Dietary Management of Functional GI Symptoms: The FODMAP Approach
FODMAP Chart & Cheatsheet
The Role of Food & Dietary Intervention in IBS
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Salix stock down 20% and...
http://www.newsobserver.com/2011/03/06/1032699/drugmakers-wait-for-fda-to-rule.html
Cheers.
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ibs-d (pseudo)with pain and bloating
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As expected:
http://www.businesswire.com/news/home/20110308005800/en/Salix-Receives-Anticipated-FDA-Complete-Response-Letter
Cheers.
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ibs-d (pseudo)with pain and bloating
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